Patient risk management in laboratory medicine: an international survey to assess the severity of harm associated with erroneous reported results
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View abstract on PubMed
Summary
This summary is machine-generated.Medical laboratory professionals worldwide perceive significant patient harm from erroneous results, with most analytes rated as serious risk. This study highlights the critical need for patient-centered risk management policies in clinical laboratories.
Area Of Science
- Clinical Laboratory Science
- Patient Safety
- Risk Management
Background
- Patient risk management is integral to international laboratory quality standards (ISO 15989:2022, ISO 22367:2020, CLSI EP23).
- Risk analysis, crucial for management, involves categorizing patient harm severity from laboratory errors.
- Limited literature and recommendations exist for this subjective risk categorization task.
Purpose Of The Study
- To conduct an international survey of medical biology professionals to assess perceived patient harm from erroneous laboratory results.
- To gather data on the severity of harm associated with 20 specific analytes.
- To inform the development of patient-centered risk management policies in clinical laboratories.
Main Methods
- An international online survey was distributed to medical biology professionals via Bio-Rad®'s customer base and the public.
- Participants rated the potential harm of 20 analytes using a five-category scale: negligible, minor, serious, critical, and catastrophic.
- Demographic data of respondents were also collected.
Main Results
- Data from 267 respondents across 43 countries were analyzed.
- Nearly all analytes (19/20) were categorized as posing at least a serious harm risk.
- No analytes were classified in the negligible harm category.
Conclusions
- This study represents the first international effort to gauge laboratory professionals' perceptions of patient harm from erroneous results.
- The findings underscore the significant perceived risk associated with laboratory errors.
- Results support the implementation of laboratory risk management policies prioritizing patient safety.
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